Sheaths for Implantable Fixation Devices

ABSTRACT

Sheaths for implantable fixation devices are disclosed. Sheaths have a flexible body with a perforated wall, an open end, a closed end, and a body interior sized and shaped to receive the fixation device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/776506, filed May 10, 2010, which is a continuation of U.S.application Ser. No. 11/970,196, filed Jan. 7, 2008, now U.S. Pat. No.7,731,750, which is a divisional of U.S. application Ser. No.10/862,573, filed Jun. 8, 2004, now U.S. Pat. No. 7,407,512, which is acontinuation of U.S. application Ser. No. 09/526,960, filed Mar. 16,2000, now U.S. Pat. No. 6,746,483, the disclosures of which areincorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

The invention relates to devices that fix soft tissue to supportstructures, particularly devices that fix soft tissue grafts within bonetunnels.

In certain types of surgical procedures, soft tissue grafts must befixed within a bone tunnel. For example, in anterior cruciate ligament(ACL) replacement surgery, a ligament graft is harvested from thepatient or from a donor, and implanted within the knee by securing oneend within a bone tunnel drilled through the tibia, and the other endwithin a bone tunnel drilled through the femur. Several ACLreconstructive techniques are described in Rosenberg, U.S. Pat. No.5,139,520, which is incorporated herein by reference.

Referring to FIG. 1, a ligament graft 10 can be fixed within a bonetunnel using a bone screw 12. Graft 10 is made from e.g., a single ordouble long strip of soft tissue. To implant graft 10, the middle of thestrip (not shown) is first passed in a distal direction through a firsttunnel 14 in the tibia into a second tunnel 18 in the femur, and thenattached to the femur tunnel (or attached to bone adjacent the femurtunnel) with a femur fixation device (not shown). Two approximatelyequal length segments 19 a, 19 b of the graft extend proximally from theattached middle portion through tunnels 18 and 14. The two ends 20 a, 20b of segments 19 a, 19 b terminate proximal to tibial tunnel 14.Segments 19 a and 19 b of the graft are then fixed within tibial tunnel14 by inserting bone screw 12 between the two segments, such that shaft22 of the screw presses the segments against internal wall 24 of tunnel14.

In attaching soft tissue within a bone tunnel using a bone screw, it isimportant that the tissue be rigidly fixed within the tunnel to preventslippage. When the bone involved is relatively soft (less calcified), acommon problem in elderly patients, screws may not adequately fix thegraft to the bone.

SUMMARY OF THE INVENTION

In one aspect, the invention relates to a sheath for an implantablefixation device, the sheath comprising a flexible body having a relievedwall, the body defining an interior sized and shaped to receive thefixation device and including an open end and a closed end. In anembodiment, the body defines a tube, the tube being sized and shaped toreceive the fixation device. In another embodiment, the tube is sizedand shaped to snugly receive a shaft of a bone screw fixation device. Inanother embodiment, the relieved wall comprises a mesh wall. In yetanother embodiment, the flexible body comprises a tube that defines atleast one perforation in a circumferential side wall of the tube. In afurther embodiment, the flexible body includes an interior that isflexible such that, when the fixation device is inserted into the body,the body flexibly expands to allow the fixation device to fit snuglywithin the body.

In another aspect, the invention relates to a combination comprising asheath including a flexible body having a relieved wall, the bodydefining an interior sized and shaped to receive a fixation device andincluding an open end and a closed end; and the fixation device, whereinthe fixation device is a bone screw, the bone screw having a shaft sizedand shaped to fit within the interior of the sheath. In an embodiment,the shaft of the bone screw fits snugly within the interior of thesheath. In another embodiment, the shaft includes generally roundedscrew threads. In yet another embodiment, the body defines a tube, thetube being sized and shaped to receive the fixation device. In a furtherembodiment, the relieved wall comprises a mesh wall. In yet a furtherembodiment, the flexible body comprises a tube that defines at least oneperforation in a circumferential side wall of the tube. In anembodiment, the flexible body includes an interior that is flexible suchthat, when the fixation device is inserted into the body, the bodyflexibly expands to allow the fixation device to fit snugly within thebody.

In yet another aspect, the invention relates to a combination comprisinga sheath including a flexible body defining a tube having an open endand a closed end, the tube defining an interior sized and shaped toreceive a fixation device and a soft tissue graft; and the fixationdevice, the fixation device configured to be received within the sheathsuch that the fixation device extends over a majority of the length ofthe tube. In an embodiment, the body includes a relieved wall. Inanother embodiment, the relieved wall comprises a mesh wall. In yetanother embodiment, the tube defines at least one perforation in acircumferential side wall of the tube. In a further embodiment, theinterior of the tube is flexible such that, when the fixation device andthe soft tissue graft are inserted into the tube, the tube flexiblyexpands to allow the fixation device and the soft tissue graft to fitsnugly within the tube.

The invention may include one or more of the following advantages.

The flexibility and thinness of certain embodiments of the sheath allowsthe sheath to conform, e.g., to the shape of the fixation device, or tothe shape of a bone tunnel.

In certain embodiments, the sheath protects the soft tissue graft fromlaceration or cutting by threads of a fixation screw, and reducestwisting of the graft upon insertion of a screw.

The relief in the sheath, e.g., perforations in a wall of the sheath,allows in situ contact between a soft tissue graft and the wall of abone tunnel, promoting development of Sharpy-like fibers and permanentattachment of the soft tissue to the bone.

Therapeutic agents, such as osteoinductors or growth factors, can bedisposed on or embedded into the material of the sheath, allowingdelivery of the agent directly to the site of fixation.

Other embodiments and advantages of the invention will be apparent fromthe following description and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sectional view of a prior art technique of fixing a ligamentgraft within a tibial bone tunnel by using a bone screw;

FIG. 2A is a perspective view of a bone screw sheath;

FIG. 2B is a sectional view of the bone screw sheath of FIG. 2A;

FIG. 2C is a sectional view of the bone screw of FIG. 1;

FIG. 3 is a sectional view of a the bone screw and sheath of FIGS. 2A-2Cfixing a ligament graft within a bone tunnel in the tibia;

FIGS. 4 and 5 are sectional views illustrating alternative arrangementsfor the bone screw, sheath, and graft of FIG. 3 within the bone tunnelin the tibia;

FIG. 6 is a perspective view of an alternative embodiment of the sheathof FIG. 2A;

FIG. 7A is a perspective view of an alternative embodiment of the sheathof FIG. 2A that includes a washer;

FIG. 7B is a top view of the washer of FIG. 7A;

FIG. 8 is a perspective view of an alternative bone screw sheath thatincludes two tubes;

FIG. 9 is a perspective view of an alternative bone screw sheath thatincludes four tubes arranged to form a ring; and

FIG. 10 is a perspective view of the bone screw sheath of FIG. 9 with anexternal sleeve.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Embodiments of the invention feature sheaths that surround bone screwsand soft tissue grafts to improve fixation of the grafts. In itssimplest form, the sheath is a flexible, mesh tube that surrounds onlythe bone screw, both the bone screw and the graft, or only the graft. Inother embodiments, the sheath includes multiple tubes.

Referring to FIGS. 2A-2C, a sheath 50 has a tube-shaped body 52 thatdefines a generally cylindrical exterior surface 53 and a generallycylindrical interior 54. Body 52 is formed from a biocompatible materialwoven into a mesh structure. The mesh defines numerous holes 56 thatexpose interior 54 to the outside. Sheath 50 also has two circular, openends 58 a, 58 b, allowing a tissue graft to pass entirely through theinterior of the sheath.

Interior 54 of sheath 50 is sized and shaped to receive bone screw 12.Sheath 50 has an internal diameter D₁ greater than the diameter D_(S) ofbone screw 12, so that both screw 12 and segments 19 a and 19 b of graft10 can fit snugly within the sheath. The sheath has a length L₁ slightlylarger than the length L_(S) of screw 12. The mesh body 52 is thin andflexible, allowing the sheath to adjust to snugly surround the screw;body 52 can be compressed to reduce the volume of interior 54, twisted,or stretched. Since sheath 50 is thin and flexible rather than rigid, itcannot on its own shore up soft bone, or fix a graft within a bonetunnel. (I.e., sheath 50 is not designed to be used alone as a fixationdevice or as a solid, rigid reinforcement of soft bone.)

In some embodiments, the threads forming the mesh body 52 are larger inthe radial direction than in the axial direction. This difference inthread size results in sheath 50 being less flexible radially thanaxially. In these embodiments, the diameter D₁ is more resistant toexpansion or contraction than length L₁. In other embodiments, thethread size is equal throughout body 52.

Diameter D₁ is, e.g., between about 8 and 10 mm, and L₁ is, betweenabout 25 and 40 mm. If sheath 50 is designed for a 7×25 bone screw (7 mmdiameter, 25 mm length), then L₁ is, e.g., about 30 mm, and D₁ is, e.g.,about 9 mm. Most of exterior surface 53 is open. For example, about 40%of the area exterior surface 53 is mesh strands, and about 60% is holes56. The thickness T₁ the mesh wall of sheath 50 is, for example, lessthan about 0.3 mm, e.g., about 0.1-0.2 mm.

Body 52 can be made from a variety of bioabsorbable materials, includingpolylactic acid, or polylactic glycolic acid. Alternatively, body 52 canbe made from a blend of absorbable materials, or from a non-absorbablematerial, such as a polyester. The material forming the body preferablyhas a higher coefficient of friction than graft 10, so that exteriorsurface 53 of the sheath grips internal wall 24 of bone tunnel 14 morefirmly than graft 10 alone, improving fixation.

Body 52 can be formed, e.g., by weaving, braiding, knitting, orcrocheting strands of the material to form the cylindrical shape, or byextrusion, using techniques known in the art. The strands forming body52 have diameters of about 0.1-1.0 mm, e.g., 0.4-0.6 mm, or 0.51 mm.

Although sheath 50 can be used with a variety of fixation screws, screw12 preferably has blunt or rounded screw threads, as opposed to sharpthreads, so that the threads do not cut the sheath or the soft tissuegraft. A typical rounded-thread screw is shown in Roger et al., U.S.Pat. No. 5,383,878, which is incorporated herein by reference.

Referring to FIG. 3, in operation, a surgeon first forms bone tunnels 14and 18 within the tibia and femur, respectively. Next, graft 10 is fixedto the femur tunnel using any technique known in the art (not shown).For example, the femur fixation device can include a loop attached tothe femur at a distal end of femur tunnel 18. End 20 a of the graft ispassed distally through tunnels 14 and 18, passed through the loop, andthen pulled proximally through tunnels 18 and 14 until the middleportion of the graft is centered on the loop. Alternatively, the graftcan be threaded through the loop prior to implantation of the loop. Inaddition, rather than using a loop, one end of graft 10 can be fixedwithin the femur tunnel, allowing the other end to extend proximallythrough tunnels 18 and 14. To increase the number of segments availablefor fixation, multiple strips of soft tissue (i.e., multiple grafts) canbe separately attached to the femur. Various techniques for attaching agraft within a bone tunnel are described in Ferragamo, U.S. Pat. No.5,769,894, which is incorporated herein by reference, and in Rosenberg,supra.

After attaching graft 10 within (or adjacent to) femur tunnel 18, thesurgeon passes ends 20 a, 20 b of graft 10 through interior 54 of sheath50 (via open ends 58 a and 58 b), and then slides sheath 50 into tibialtunnel 14. The diameter of tunnel 14 is only slightly larger than theouter diameter of sheath 50, such that sheath 50 fits snugly withintunnel 14. Alternatively, sheath 50 can be inserted into tunnel 14 priorto passing the graft through the sheath. To insert sheath 50 into tibialtunnel 14, the surgeon can use a delivery tool, such as a rigid tubedetachably fixed to the distal end of the sheath. Alternatively, asuture can be threaded through the distal end of sheath 50, and thesheath can be pulled into place within tunnel 14 using the suture.

The surgeon then inserts bone screw 12 into interior 54 of sheath 50,between segments 19 a and 19 b of the graft. The screw may be insertedusing an insertion tool known in the art, such as a screw driver. Whenscrew 12 is in place as shown in FIG. 3, the screw presses segments 19 aand 19 b of the graft against the interior surface of sheath 50, andpresses exterior surface 53 of the sheath against wall 24, fixing thegraft within the tunnel.

As shown in FIG. 3, when screw 12 is inserted, it will typically beslightly off center, such that the screw's threads dig into wall 24 ofbone tunnel 14 along a segment 24 a of wall 24. For example, if screw 12has a major diameter of 9 mm, and a minor diameter of 7 mm, then thescrew threads will dig into wall 24 by about 1 mm along segment 24 a,where segment 24 a is about 120 degrees. This engagement of the threadswith segment 24 a of the wall helps hold screw 12 within tunnel 14, andtherefore improves fixation of graft 10 within the tunnel.

The presence of sheath 50 within bone tunnel 14 improves fixation ofgraft 10. Since exterior surface 53 of sheath 50 has a highercoefficient of friction than graft 10, sheath 50 is less likely thangraft 10 (which is made of tissue) to slide along wall 24 of the tunnel,or to twist when screw 12 is inserted into the tunnel. In addition,since body 52 of sheath 50 has a mesh structure, portions of graft 10protrude through holes 56 of the mesh, resisting sliding of graft 10relative to sheath 50. The flexibility of sheath 50 allows the sheath toconform to the shape of wall 24, maximizing the surface area contactbetween the exterior surface of the sheath and wall 24, therebyincreasing frictional forces between the sheath and the wall.

After screw 12 has been inserted into tunnel 14, the surgeon may trimthe portions of segments 19 a and 19 b that extrude proximally fromtunnel 14, completing the surgical procedure. Over time, graft 10permanently affixes to wall 24 by growth of Sharpy-like fibers betweenthe soft tissue of graft 10 and the bone tissue of wall 24.(“Sharpy-like fibers” are collagenous fibers that grow from bone into asoft tissue graft. The presence of Sharpy-like fibers indicate good bonygrowth to the graft, and therefore good fixation. See Pinczewski et al.,“Integration of Hamstring Tendon Graft With Bone in Reconstruction ofthe Anterior Cruciate Ligament,” Arthroscopy, 13: 641-43 (1997). Theopen holes 56 in body 52 of the sheath facilitate permanent fixation byincreasing the direct contact between the graft and the bone tunnelwall. Sheath 50 eventually dissolves, and new bone grows to fill itsposition.

To accelerate bone growth and permanent attachment of graft 10 to wall24, sheath 50 can include an osteoinductive agent, such ashydroxyapatite, tricalcium phosphate, calcium sulphate, or a “ceramic”(a calcium and potassium crystalline). The osteoinductive agent can beapplied to sheath 50 prior to surgery by, e.g., spraying the sheath withthe agent, by dipping the sheath into a bath that includes the agent, bydusting or spraying the agent onto the sheath, or by filling the sheathwith a gel that includes the agent. In addition, the strands of materialforming the mesh body 52 can be hollow, and the agent can be within thehollow interiors of the strands. Alternatively, the agent can beincorporated into the material that forms body 52. For example, theagent can be blended into the material used to make the threads thatform mesh body 52, or can be added to the fibers as an osteoinductivefelt.

Other therapeutic agent, such as growth factors (e.g., tissue growthfact or platelet derived growth factor), bone morphogenic proteins, stemcells, osteoblasts, and cytokines, can also be included in the sheath.These bioactive agents can be added using the techniques describedabove, or can be blended into the material that forms body 52 usingmicro-encapsulation or nanoparticles. For example, body 52 can be formedfrom a material comprising microspheres of the agent and a polymer, suchas polylactic glycolic acid. The microspheres of the agent and polymercan be prepared using known techniques. See, e.g., Cohen et al.,“Controlled Delivery Systems for Proteins Based on Poly(Lactic/GlycolicAcid) Microspheres,” Pharm. Research, 8:713-20 (1991); DeLuca et al.,U.S. Pat. Nos. 5,160,745 and 4,741,872. Rather than formingmicrospheres, the agent and polymer can also be mixed together using,e.g., sintering techniques. See, Cohen et al., “Sintering Techniques forthe Preparation of Polymer Matrices for the Controlled Release ofMacromolecules,” J. Pharm. Sciences, 73:1034-37 (1984). The bioactiveagents can also be attached to body 52 using adhesives or electricalcharge, or can be directly loaded onto the sheath by a deliverymechanism after implantation of the sheath.

Other embodiments are within the scope of the claims. For example, thesheath can be used to assist fixation of a bone screw within the femurtunnel 18, in addition to the tibial tunnel 14.

Referring to FIG. 4, screw 12 can be placed between sheath 50 and wall24 of tunnel 14. In this embodiment, rather than inserting screw 12 intothe sheath after placement of the sheath within tunnel 14, screw 12 isinserted into tunnel 14 along the side of the sheath. To hold screw 12to the side of the sheath, the sheath can optionally include an externalloop 102. Loop 102 has a diameter slightly larger than the diameter ofscrew 12, so that shaft 22 of screw 12 fits snugly within the loop. Loop102 can be made from the same material as body 52, or can be made froman inflexible, rigid material.

When screw 12 is inserted, it compresses graft 10 within the sheath, andpresses exterior surface 53 of the sheath against wall 24, fixing graft10 within tunnel 14.

Referring to FIG. 5, segments 19 a and 19 b of graft 10 can bepositioned radially outside of sheath 50. In this embodiment, whensheath 50 is inserted into tunnel 14, it is located between ends 19 aand 19 b of the graft, so that the graft surrounds the sheath, ratherthan the sheath surrounding the graft. Screw 12 is then inserted intothe sheath, pressing segments 19 a and 19 b between exterior surface 53of the sheath and wall 24, fixing the graph in place. Alternatively, thescrew can first be inserted into the sheath, and then the sheath andscrew together can be positioned within the bone tunnel.

The structure of the bone screw sheath can be modified as well. Thediameter D1, length L1, and thickness T of the sheath can be varied toaccommodate different sized bone tunnels, different sized screws, anddifferent deployment methods. For example, in the deployment method ofFIG. 5, the inner diameter D1 of the sheath can be approximately equalto the diameter DS of the screw shaft, so that the screw fits verysnugly within the sheath, and exterior surface 53 of the sheath conformsto the shape of the screw shaft.

In the deployment methods shown in FIGS. 4 and 5, the sheath need, notbe more rigid in the radial direction than in the axial direction. Thethreads forming the mesh body, therefore, are generally the same size inboth the radial and axial directions. In addition, sheaths used in thedeployment method of FIG. 5 can have less open space than sheaths usedwith the method of FIG. 3 or 4. (I.e., less than 60% of the sheath'ssurface area will be holes.)

If the bone is particularly soft, sheath 50 can be woven tighter, sothat the sheath is less flexible, thereby providing a more firmsubstrate for screw 12 to engage.

The sheath need not have a mesh structure. For example, the sheath canhave a solid body with holes cut through the body, allowingcommunication between the exterior and interior of the sheath. Inaddition, the sheath's body need not be integrally formed. For example,the body can be formed by winding a strip of material around animplantable device to form a relieved body that defines an interior.

The sheath can have relief structures other than holes to allowcommunication between the exterior and interior. For example, othertypes of perforations, such as slits, can be used, instead of holes. Inaddition, the device can have a solid wall with thinned sections. Whenimplanted, the thinned sections biodegrade more quickly than othersections of the wall, such that in situ, the device developsperforations.

To increase the coefficient of friction of exterior surface 53 toimprove fixation of the sheath within the bone tunnel, exterior surface53 can have a roughened finish.

Referring to FIG. 6, rather than having two open circular ends, sheath150 has an open end 158 a and a closed end 158 b. Closed end 158 b givessheath a “bag” or “sock” shaped structure.

Referring to FIG. 7A, a sheath 250 includes a washer 280 attached to theproximal end 282 of the sheath. The washer 280 has a diameter D2 that islarger than diameter D1 of sheath 250, and is larger than the diameterof the bone tunnel. Washer 280 prevents proximal end 282 of the sheathfrom passing into the bone tunnel when the screw is inserted into thesheath, thereby ensuring that the sheath is ultimately positioned aroundthe screw shaft, rather than in front of the screw. Rather than beingcircular, the washer can be square, triangular, or any other shape, solong as it has a dimension larger than the diameter of the bone tunnel.Referring to FIG. 7B, the upper surface 284 of the washer can includeteeth or spikes 286 to grip bone, thereby reducing twisting of sheath250 when a bone screw is inserted into the sheath. The washer can bemade from a bioabsorbable material, or a non-absorbable, biocompatiblematerial. In operation, the washer can be detached from the sheath afterimplantation of the graft and bone screw, or can be left attached to thesheath.

Referring to FIG. 8, a sheath 350 includes two contiguous, parallel meshtubes, 352 a and 352 b. Tubes 352 a and 352 b are integrally woven,braided, knitted, or crocheted from threads. Each tube has a diameter D3that is slightly larger than diameter DS of screw 12, and slightly lessthan diameter D1 of sheath 50. Diameter D3 can be, e.g., 2 mm, 4 mm, 6mm, or 8 mm. Sheath 50 has a length L3 approximately equal to the lengthof a fixation screw, e.g., about 10-50 mm, or 20-35 mm. The walls 354 a,354 b of tubes 352 a and 352 b each have a thickness of, e.g., between0.1 mm and 1.0 mm.

In operation, a soft tissue graft is passed through one of the tubes(e.g., tube 352 a), and the fixation screw is inserted into the secondtube (e.g., tube 352 b). When the sheath, graft, and fixation screw arepositioned within the bone tunnel, tube 352 a is compressed between thescrew and a wall of the bone tunnel. The graft, therefore, is compressedwithin tube 352 a, fixing the graft within the bone tunnel.

Referring to FIG. 9, a sheath 450 includes four parallel mesh tubes, 452a, 452 b, 452 c, and 452 d. The four tubes are arranged to form a ring454. Ring 454 defines a central cavity 456 disposed between the tubes.The cavity defines an axial bore that is coextensive with the axiallengths of each of the tubes.

Each tube 452 a, 452 b, 452 c, and 452 d has a diameter D4 and a lengthL4 similar to diameter D3 and length L3 of sheath 350 (FIG. 8). As withsheath 350, the tubes of sheath 450 are integrally woven.

In operation, segments of a soft tissue graft are passed through each oftubes 452 a-452 d. The surgeon can either use multiple, independenttissue grafts separately attached to the femur tunnel, or can split theproximal end of a single graft into four separate segments. The sheathis then inserted into the tibial bone tunnel, and a fixation screw isinserted into central cavity 456. When the sheath, soft tissue, andscrew are in place within the bone tunnel, the tubes are compressedbetween the screw and the bone tunnel wall, and the soft tissue segmentsare compressed within each tube, thereby fixing the soft tissue withinthe bone tunnel.

In the embodiment shown FIG. 9, sheath 450 includes four tubes forming aring. The sheath need not, however, be limited to this number. Forexample, the sheath can include a ring of 3, 5, 6, 7, or 8 tubes. Inaddition, soft tissue need not be passed through each tube. For example,soft tissue segments can be passed through two tubes, leaving theremaining tubes unoccupied.

Instead of being integrally woven, the tubes of sheath 450 can be woven,braided, or knitted separately, and attached together using, e.g.,stitching, spot welding, or an adhesive. The tubes can also be solidrather than mesh, and need not all have the same diameter. In addition,unlike the single tube sheaths of FIGS. 2A, 6, and 7, sheath 450 can berigid, rather than flexible.

Referring to FIG. 10, sheath 550 is identical to sheath 450 in allrespects, except that sheath 550 further includes a mesh sleeve 580 thatsurrounds the four tubes 552 a-552 d. Sleeve 580 is axially coextensivewith tubes 552 a-552 d, and is integrally woven with the four tubes.Alternatively, sleeve 580 can be a separate solid or mesh structureadhesively bound to the four tubes. Sleeve 580 acts to stabilize sheath550, and facilitates insertion of the sheath into the bone tunnel. Forexample, to insert sheath 550, a suture or delivery tool can be attachedto sleeve 580, rather than directly to one of the tubes.

The sheaths need not be used exclusively with bone screws or bonetunnels. Rather, the invention includes sheaths that improve fixation ofother types of implantable fixation devices, such as soft tissue tacks,plugs, and suture anchors. The size and shapes of the sheaths can bevaried to accommodate the different types of fixation devices. Forexample, in one embodiment, soft tissue can be positioned inside of asheath, and the sheath can be attached to the side of a bone with afixation device such as a tack.

1. A sheath for an implantable fixation device, the sheath comprising: aflexible body having a relieved wall, the body defining an interiorsized and shaped to receive the fixation device and including an openend and a closed end.
 2. The sheath of claim 1, wherein the body definesa tube, the tube being sized and shaped to receive the fixation device.3. The sheath of claim 2, wherein the tube is sized and shaped to snuglyreceive a shaft of a bone screw fixation device.
 4. A combinationcomprising: a sheath including: a flexible body having a relieved wall,the body defining an interior sized and shaped to receive a fixationdevice and including an open end and a closed end; and the fixationdevice, wherein the fixation device is a bone screw, the bone screwhaving a shaft sized and shaped to fit within the interior of thesheath.
 5. The combination of claim 4, wherein the shaft of the bonescrew fits snugly within the interior of the sheath.
 6. The combinationof claim 4, wherein the shaft includes generally rounded screw threads.7. The combination of claim 4, wherein the body defines a tube, the tubebeing sized and shaped to receive the fixation device.
 8. A combinationcomprising: a sheath including: a flexible body defining a tube havingan open end and a closed end, the tube defining an interior sized andshaped to receive a fixation device and a soft tissue graft; and thefixation device, the fixation device configured to be received withinthe sheath such that the fixation device extends over a majority of thelength of the tube.
 9. The sheath of claim 1, wherein the relieved wallcomprises a mesh wall.
 10. The sheath of claim 1, wherein the flexiblebody comprises a tube that defines at least one perforation in acircumferential side wall of the tube.
 11. The sheath of claim 1,wherein the flexible body includes an interior that is flexible suchthat, when the fixation device is inserted into the body, the bodyflexibly expands to allow the fixation device to fit snugly within thebody.
 12. The combination of claim 4, wherein the relieved wallcomprises a mesh wall.
 13. The combination of claim 4, wherein theflexible body comprises a tube that defines at least one perforation ina circumferential side wall of the tube.
 14. The combination of claim 4,wherein the flexible body includes an interior that is flexible suchthat, when the fixation device is inserted into the body, the bodyflexibly expands to allow the fixation device to fit snugly within thebody.
 15. The combination of claim 8, wherein the body includes arelieved wall.
 16. The combination of claim 15, wherein the relievedwall comprises a mesh wall.
 17. The combination of claim 8, wherein thetube defines at least one perforation in a circumferential side wall ofthe tube.
 18. The combination of claim 8, wherein the interior of thetube is flexible such that, when the fixation device and the soft tissuegraft are inserted into the tube, the tube flexibly expands to allow thefixation device and the soft tissue graft to fit snugly within the tube.